The present invention relates to a system which assists in the closure of puncture or other wounds in the vasculature of a patient. Specifically, the invention relates to devices which aid in locating and isolating the wound in the vasculature and guiding an appropriate wound closure device to the site, so that the wound may be closed using surgical clips, sutures, or staples.
Transluminal balloon angioplasty is used in the treatment of peripheral vascular disease to increase or restore blood flow through a significantly narrowed artery in a limb; it is also used in the treatment of blockage of the coronary arteries. In fact, coronary angioplasty has emerged as a major viable alternative to bypass surgery for revascularization of stenotic and occluded coronary arteries. Unlike bypass surgery, angioplasty does not require general anesthesia, opening of the chest wall, use of a heart-lung machine, or transfusion of blood. Angioplasty is not only less invasive and less traumatic to the patient, it is also less expensive because of the shorter hospital stay and shorter recovery time.
Transluminal balloon angioplasty is performed by first inserting a hollow needle through the skin and into the patient""s femoral artery. A guidewire is advanced through the hollow needle and into the artery, then along the patient""s vasculature toward the site of the blocked blood vessel or heart valve to be treated. X-ray imaging is used to help move the guidewire through the vascular system and into position just past the stenosis to be treated. A balloon catheter is then threaded over the guidewire and advanced until the deflated balloon is within the stenosis. The balloon is then repeatedly inflated to widen the narrowed blood vessel. After the procedure is complete, the catheter and guidewire are withdrawn from the blood vessels and the patient.
Angiography, which is used to detect diseases that alter the appearance of blood vessels, is performed in a similar manner. A hollow needle is first inserted through the skin and into the femoral artery, and a guidewire is then inserted through the needle and into the affected blood vessel. A catheter is then threaded over the guidewire and into the blood vessel to be examined, using x-ray imaging to guide the catheter to the desired position. Contrast medium is then injected, and a rapid sequence of x-ray pictures are taken so that blood flow along the affected vessel can be studied. Once complete, the catheter and guidewire are removed from the patient""s body.
After the catheter and guidewire used during angioplasty or angiography are removed, the puncture wound in the femoral artery must be closed and the bleeding through the puncture site in the artery stopped. Currently, ice packs and/or pressure are applied to the artery for a period lasting up to several hours in an attempt to stop the bleeding. There exists, however, a significant chance that upon movement by the patient, the wound will reopen and begin bleeding again. Although efforts have been made to close the puncture wound using staples, clips, and sutures, they have been unsuccessful, largely due to the inability to clearly locate and visualize the puncture wound in the femoral artery.
Other wounds in the vasculature of a patient can also be difficult to locate and access. Thus, a device and method to facilitate the closure wounds in the vasculature of a patient, such as femoral artery puncture wounds following transluminal balloon angioplasty and angiography, would be extremely beneficial. A device having the ability to aid in locating the puncture wound and facilitating the closure of the wound using staples, clips, or sutures would eliminate the prolonged bleeding currently associated with such wounds.
The wound closure system of the present invention aids in locating and isolating a puncture wound in the vasculature of a patient. The system can be used in conjunction with a guidewire which is normally inserted into the vasculature during diagnostic and therapeutic procedures. The devices of the present invention aid the physician in closing the wound, thus eliminating prolonged bleeding associated with these procedures.
In accordance with one aspect of the present invention, there is provided a device to facilitate the closure of wounds in the femoral artery. This retractor comprises a body portion separable into two halves, each of the halves having a flat internal surface with a groove, such that when the internal surfaces abut one another, the grooves form a channel through the entire length of the body portion. The retractor has a collar portion at one end, having at least one guide passage which traverses both halves of the body portion, and at least one pin which is insertable into the guide passage. A handle extends laterally from the pin to allow the user to easily manipulate the device. At least one set screw hole can be provided in the collar portion at a right angle to the guide passage, and at least one set screw inserted into the set screw hole to secure the device to the pins.
The device can be made of a biocompatible engineering polymer, such as polypropylene, polyethylene, or polyterephthalate. Alternatively, an elastomer or a metal can be used to make the device.
A hollow dilator adapted to receive a guidewire is preferably used in conjunction with the retractor. The dilator is inserted through the channel in the body portion of the retractor, and extends past the distal end of the reactor. The dilator preferably includes at least one indicator hole located at the distal end, which extends past the end of the retractor. The dilator has a double-sleeved inflatable balloon mounted on its distal end just proximal to the indicator hole, and a second inflatable balloon mounted just distal to the indicator hole. These balloons help anchor the dilator in place, and provide access to the puncture wound from the surface of the patient""s body. A guidewire is used to help guide the insertion of the dilator. The guidewire is inserted through the hollow dilator, and the dilator advanced over the guidewire into its proper position.
Another aspect of the present invention includes a system for facilitating the closure of wounds in the vasculature of a patient. The system includes a retractor as described above, a hollow dilator adapted to receive a guidewire, and a guidewire. The guidewire is inserted through the dilator, and the dilator is inserted through the channel in the retractor. Preferably, a guide assembly adapted to be reversibly attached to a surgical clip applicator is used. The guide assembly receives the guidewire to help guide the clip applicator to the site of the puncture wound.
The dilator preferably has a source of negative pressure connected to its proximal end in fluid communication with the hollow dilator. The source of negative pressure can be a syringe or any other appropriate source.
A method for facilitating the closure of a wound in the vasculature of a patient is also described. A guidewire is first inserted into the patient""s vasculature through the wound, until the distal end of the guidewire is within the vasculature and the proximal end remains outside the patient""s body. The proximal end of the guidewire is inserted into the distal end of a hollow dilator having a double-sleeved balloon and a second balloon distal the double-sleeved balloon mounted on it. The dilator is advanced over the guidewire until it reaches the wound. The balloons are inflated to anchor the dilator in position, and the proximal end of the dilator is inserted into the distal end of a retractor. The retractor is advanced between the two sleeves of the double-sleeved balloon. The two halves of the retractor are separated and the dilator and the inner sleeve of the double-sleeved balloon are removed from the patient. Using the retractor and the outer sleeve of the balloon as a guide, the wound is accessed and closed by means such as clipping, stapling, or suturing.
Preferably, a source of negative pressure is provided on the proximal end of the dilator during insertion, until blood is drawn into the dilator from the vasculature. This assists the user in determining when the dilator is properly positioned.
A hollow indicator tube mounted on a surgical clip applicator is preferably used to close the wound. The applicator is advanced over the guidewire and through the channel in the retractor until the applicator contacts the wound. To aid proper insertion, a source of negative pressure is provided at the proximal end of the indicator tube, until blood is drawn into the indicator tube from the vasculature.
In yet another embodiment of the retractor used to facilitate wound closure, the retractor has a body portion and a handle portion. At its distal end, the body portion has a retracting portion having two movable halves which extend away from the body portion. The halves are formed such that when the internal surfaces abut one another, a channel is formed which extends completely through the retracting portion. The handle portion connects to the body portion and controls the movement of the two moveable halves. Preferably, the handle portion comprises two handles, and a loop extending from one handle to the other. This loop surrounds a screw mounted on the other handle. This locking mechanism acts to secure the position of the handles and the retracting portion of the retractor.
A hollow catheter having an open proximal end and an open distal end, adapted to receive a guidewire therethrough, is used in conjunction with the retractor. The hollow catheter is inserted through the channel in the retracting portion of the retractor. The catheter is preferably a dual-lumen catheter, having an inner lumen adapted to receive a guidewire, and an outer lumen which surrounds the inner lumen. The outer lumen has at least one indicator hole located in an outer wall to allow for the aspiration of blood through the outer lumen. This helps position the catheter properly within the patient""s body.
The retractor and dual-lumen catheter are used in the following manner. The retractor is mounted on the outside of the distal end of the catheter, approximately 0.5 mm behind the indicator hole located in the outside wall of the catheter. The proximal end of a guidewire which is already in place in the patient as a result of a diagnostic or therapeutic procedure, is inserted into the distal end of the inner lumen of the dual-lumen catheter, and the catheter and retractor are advanced as a single unit over the guidewire.
Preferably, a source of negative pressure is provided at the proximal end of the outer lumen of the dual-lumen catheter during its advancement. As soon as blood is drawn into the outer lumen through the indicator hole, advancement of the catheter and retractor are stopped. The two halves of the retracting portion are then separated to expose the wound, the catheter and guidewire are removed, and the wound is closed.
Further, a second catheter having an inflatable balloon on its distal end may be used. Once the retractor and double-lumen catheter are in place, the guidewire is removed from the patient through the inner lumen of the dual-lumen catheter. The inner catheter having an inflatable balloon mounted on its distal end is inserted through the inner lumen of the dual-lumen catheter and into the patient. Once inside the vasculature, the balloon is inflated and drawn in a proximal direction until resistance is felt. This helps to anchor the catheter in place as well as stop the bleeding during the closing of the wound. The dual-lumen catheter is removed, and the inner catheter is used to guide a closing device to the wound. The wound is closed as the balloon is deflated and the inner catheter is removed. Finally, the retractor is removed.
The present invention advantageously provides a simple and safe method of facilitating the closure of a wound in the vasculature of a patient, and the devices which facilitate this method. A retractor, used in conjunction with a guidewire, dilator or catheter, helps locate and isolate the site of the puncture wound in the patient. The retractor moves the surrounding tissue laterally as it is advanced into the patient, and acts as a guide for the physician in locating the exact site of the wound. The retractor is preferably used in combination with a surgical clip applicator which delivers clips to the site of the wound, but can also be used with other methods of wound closure such as suturing and stapling. The present invention eliminates the prolonged bleeding associated with current cardiac diagnostic and therapeutic procedures, and provides a significant advancement in the medical field.